South Florida Sun-Sentinel Palm Beach (Sunday)
Devices to treat pain bring it
Many hurt by hyped, ill-regulated medical implants
COLUMBIA, S.C. — Desperate for relief after years of agony, Jim Taft listened intently as his pain management doctor described a medical device that could change his life.
It wouldn’t fix the nerve damage in his mangled right arm, Taft and his wife recalled the doctor saying, but a spinal-cord stimulator would cloak his pain, making him “good as new.”
But Taft’s surgically implanted stimulator failed when a wire along his spine broke. After an operation to repair it, he said the device shocked him so many times that he couldn’t sleep and even fell down a flight of stairs. Today, the 45-yearold Taft is a prisoner in his own bed, barely able to get to the bathroom by himself.
“I thought I would have a wonderful life,” he said. “But look at me.”
For years, medical device companies and doctors have touted spinal-cord stimulators as a panacea for millions of patients suffering from a wide range of pain disorders, making them one of the fastestgrowing products in the $400 billion medical device industry. Companies and doctors aggressively push them as a safe antidote to the deadly opioid crisis in the U.S. and as a treatment for an aging population in need of chronic pain relief.
But the stimulators — devices that use electrical currents to block pain signals before they reach the brain — are more dangerous than many patients know, an Associated Press investigation found. They account for the third-highest number of medical device injury reports to the U.S. Food and Drug Administration, with more than 80,000 incidents flagged since 2008.
Patients report that they have been shocked or burned or have suffered spinal-cord nerve damage ranging from muscle weakness to paraplegia, FDA data show. Among the 4,000 types of devices tracked by the FDA, only metal hip replacements and insulin pumps have logged more injury reports.
The FDA data contain more than 500 reports of people with spinal-cord stimulators who died, but details are scant, making it difficult to determine if the deaths were related to the stimulator or implant surgery.
Medical device manufacturers insist spinal-cord stimulators are safe — about 60,000 are implanted annually — and doctors who specialize in these surgeries say they helped reduce pain for many of their patients.
Most of these devices have been approved by the FDA with little clinical testing, however, and the agency’s data show that spinalcord stimulators have a disproportionately higher number of injuries compared to hip implants, which are far more plentiful.
The AP reported on spinal stimulators as part of a nearly yearlong joint inves- tigation of the global medical devices industry that included NBC, the International Consortium of Investigative Journalists and more than 50 other media partners around the world. Reporters collected and analyzed millions of medical records, recall notices and other product safety warnings, in addition to interviewing doctors, patients, researchers and company whistleblowers.
The media partners found that, across all types of medical devices, more than 1.7 million injuries and nearly 83,000 deaths were reported to the FDA over the last decade.
The investigation also found that the FDA pushes devices through an abbreviated approval process, then responds slowly when it comes to forcing companies to correct sometimes life-threatening products.
Devices are rarely pulled from the market, even when major problems emerge.
The FDA acknowledges its data have limitations, including mistakes, omissions and under-reporting that can make it difficult to determine whether a device directly caused an injury or death. But it rejects any suggestion of failed oversight.
“There are over 190,000 different devices on the U.S. market. We approve or clear about a dozen new or modified devices every single business day,” Dr. Jeffrey Shuren, the FDA’s medical device director said at an industry conference in May. “The few devices that get attention at any time in the press is fewer than the devices we may put on the market in a single business day.”
In the last 50 years, the medical device industry has revolutionized treatment for some of the deadliest scourges of modern medicine, introducing devices to treat or diagnose heart disease, cancer and diabetes.
Pete Corby, who injured his back working as a movie stuntman, said a spinalcord stimulator helped him deal with his constant pain and stop using the opioids he’d become dependent on.
Medical device companies have “invested countless resources — both capital and human — in developing leading-edge compliance programs,” said Janet Trunzo, head of technology and regulatory affairs for AdvaMed, the industry’s main trade association.
At the same time, medical device makers also have spent billions lobbying regulators, hospitals and doctors.
Taft’s neurosurgeon, Ja- son Highsmith of Charleston, S.C., implanted the device in April 2014. But Taft and his wife say the device never worked.
In October 2014, Highsmith said he operated on Taft to install a new lead, tested the battery and reinserted it. Still, Taft’s medical records show that he continued to report numbness, tingling and pain.
The stimulator was surgically removed in August 2015.
Highsmith said the overwhelming majority of his spinal-cord stimulator patients gain significant pain relief.
That’s little comfort for Taft.
“This is my death sentence,” Taft said, stretched out beneath his bed’s wooden headboard on which he’s carved the words “death row.”
“I’ll die here,” he said.